This course is not currently scheduled but may be offered at your company site.
Please contact Fleming for more information.
All sessions of this unique course online
Live interaction options between the delegates and trainer
Available via mobile, tablet or laptop
Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!
Guidance and regulation for stability of cell and gene therapies/ ATMPs
Limitations of accelerated and stress stability assessment
Instabilities by chemical, physical and microbiological factors
Analytical methodology for stability assessment
The role of excipients in stability of ATMPs
Transport and shipping impact on stability and shelf-life
Importance of in-use stability studies
Understand
• Bracketing and matrixing to improve your product stability
Learn
• About guidance and expectations for product stability protocol
• To identify proper analytical methods for stability assessment
• To understand the requirements for Excipients and Diluents
• To differentiate between reconstitution and manufacturing steps
Gain
• A comprehensive overview on stability and shelf-life regulatory landscape
• In depth insights into cell and gene therapy productsA contact with key leaders and regulatory authority to build up your network
This course is not currently scheduled but may be offered at your company site.
Please contact Fleming for more information.
